Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults
Introduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
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| author | Florence Ader Jean-François Timsit Yazdan Yazdanpanah François-Xavier Lescure Laetitia Moinot Christelle Delmas Hélène Espérou Laurent Abel Benjamin Leveau Vinca Icard Toni Alfaiate Linda Wittkop Charles Burdet France Mentré Marion Schneider Nathan Peiffer-Smadja Julien Poissy Lila Bouadma Bruno Lina Florence Morfin-Sherpa Maude Bouscambert Alexandre Gaymard Gilles Peytavin Jeremie Guedj Claire Andrejak Cedric Laouenan Drifa Belhadi Axelle Dupont Basma Basli Anissa Chair Samira Laribi Julie Level Marie-Capucine Tellier Aline Dechanet Dominique Costagliola Sandrine Couffin-Cadiergues Juliette Saillard Claire Fougerou Carole Cagnot Soizic Le Mestre Delphine Lebrasseur-Longuet Ventzislava Petrov-Sanchez Alpha Diallo NoéMie Mercier Sarah Tubiana Benjamin Hamze Ambre Gelley Marion Noret Eric D’Ortenzio Oriane Puechal Caroline Semaille |
| author_facet | Florence Ader Jean-François Timsit Yazdan Yazdanpanah François-Xavier Lescure Laetitia Moinot Christelle Delmas Hélène Espérou Laurent Abel Benjamin Leveau Vinca Icard Toni Alfaiate Linda Wittkop Charles Burdet France Mentré Marion Schneider Nathan Peiffer-Smadja Julien Poissy Lila Bouadma Bruno Lina Florence Morfin-Sherpa Maude Bouscambert Alexandre Gaymard Gilles Peytavin Jeremie Guedj Claire Andrejak Cedric Laouenan Drifa Belhadi Axelle Dupont Basma Basli Anissa Chair Samira Laribi Julie Level Marie-Capucine Tellier Aline Dechanet Dominique Costagliola Sandrine Couffin-Cadiergues Juliette Saillard Claire Fougerou Carole Cagnot Soizic Le Mestre Delphine Lebrasseur-Longuet Ventzislava Petrov-Sanchez Alpha Diallo NoéMie Mercier Sarah Tubiana Benjamin Hamze Ambre Gelley Marion Noret Eric D’Ortenzio Oriane Puechal Caroline Semaille |
| author_sort | Florence Ader |
| collection | DOAJ |
| description | Introduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.Methods and analysis DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β−1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.Ethics and dissemination Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04315948 Eudra-CT 2020-000936-23. |
| format | Article |
| id | doaj-art-8d39c5bedf1b411e9d94566602ddf84b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8d39c5bedf1b411e9d94566602ddf84b2025-01-09T04:10:10ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-041437Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adultsFlorence Ader0Jean-François Timsit1Yazdan Yazdanpanah2François-Xavier LescureLaetitia MoinotChristelle DelmasHélène EspérouLaurent AbelBenjamin Leveau3Vinca Icard4Toni AlfaiateLinda Wittkop5Charles BurdetFrance MentréMarion SchneiderNathan Peiffer-SmadjaJulien PoissyLila BouadmaBruno LinaFlorence Morfin-SherpaMaude BouscambertAlexandre GaymardGilles PeytavinJeremie GuedjClaire Andrejak6Cedric LaouenanDrifa BelhadiAxelle DupontBasma BasliAnissa ChairSamira LaribiJulie LevelMarie-Capucine TellierAline DechanetDominique Costagliola7Sandrine Couffin-CadierguesJuliette SaillardClaire FougerouCarole CagnotSoizic Le MestreDelphine Lebrasseur-LonguetVentzislava Petrov-SanchezAlpha DialloNoéMie MercierSarah TubianaBenjamin HamzeAmbre GelleyMarion NoretEric D’Ortenzio8Oriane PuechalCaroline SemailleInfectious Diseases Department, Hospices Civils de Lyon, Lyon, FranceService de Réanimation Infectieuse, Hôpital Bichat, Assistance Publique—Hopitaux de Paris, Paris, Île-de-France, FranceInserm, IAME, UMR 1137, université Paris Diderot, Hopital Bichat - Claude-Bernard, Paris, Île-de-France, France4 Centre de ressources biologiques Nord, Hospices Civils de Lyon, Lyon, France4 Centre de ressources biologiques Nord, Hospices Civils de Lyon, Lyon, France3 Institut Bergonié, CIC-EC 1401, CHU de Bordeaux, Service d’information médicale, INSERM, Bordeaux, FranceService de Pneumologie, CHU Amiens-Picardie, UR 4294 AGIR, université Picardie Jules-Verne, 80054 Amiens, France, Amiens, FranceSorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, Paris, FranceANRS Maladies infectieuses émergentes (ANRS MIE), Inserm, Paris, FranceIntroduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.Methods and analysis DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β−1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.Ethics and dissemination Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04315948 Eudra-CT 2020-000936-23.https://bmjopen.bmj.com/content/10/9/e041437.full |
| spellingShingle | Florence Ader Jean-François Timsit Yazdan Yazdanpanah François-Xavier Lescure Laetitia Moinot Christelle Delmas Hélène Espérou Laurent Abel Benjamin Leveau Vinca Icard Toni Alfaiate Linda Wittkop Charles Burdet France Mentré Marion Schneider Nathan Peiffer-Smadja Julien Poissy Lila Bouadma Bruno Lina Florence Morfin-Sherpa Maude Bouscambert Alexandre Gaymard Gilles Peytavin Jeremie Guedj Claire Andrejak Cedric Laouenan Drifa Belhadi Axelle Dupont Basma Basli Anissa Chair Samira Laribi Julie Level Marie-Capucine Tellier Aline Dechanet Dominique Costagliola Sandrine Couffin-Cadiergues Juliette Saillard Claire Fougerou Carole Cagnot Soizic Le Mestre Delphine Lebrasseur-Longuet Ventzislava Petrov-Sanchez Alpha Diallo NoéMie Mercier Sarah Tubiana Benjamin Hamze Ambre Gelley Marion Noret Eric D’Ortenzio Oriane Puechal Caroline Semaille Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults BMJ Open |
| title | Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults |
| title_full | Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults |
| title_fullStr | Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults |
| title_full_unstemmed | Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults |
| title_short | Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults |
| title_sort | protocol for the discovery trial multicentre adaptive randomised trial of the safety and efficacy of treatments for covid 19 in hospitalised adults |
| url | https://bmjopen.bmj.com/content/10/9/e041437.full |
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